ID

37923

Description

Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 in Postmenopausal Women With Newly Diagnosed Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01230970

Link

https://clinicaltrials.gov/show/NCT01230970

Keywords

Versions (1)
  1. 8/30/19 8/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01230970

English

Eligibility Breast Cancer NCT01230970

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female subjects 55 to 80 years with histologically or cytologically documented primary intraductal or lobular invasive breast cancer that meets the following criteria:
Description

Gender | Age | Intraductal breast neoplasm Invasive | Invasive Lobular Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0948967
UMLS CUI [3,2]
C0205281
UMLS CUI [4]
C0279565
t2, n0 or n1, m0.
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
primary tumour clinically determined to be 2 to 5 cm in the greatest dimension.
Description

Tumor size, largest dimension

Data type

boolean

Alias
UMLS CUI [1]
C1272779
laboratory documentation of positive oestrogen receptor (er+) status in at least 10% of the tumour cells.
Description

Neoplastic Cells Percentage Estrogen receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0279754
laboratory documentation of her-2 negative status.
Description

HER2 Negative

Data type

boolean

Alias
UMLS CUI [1]
C2348908
postmenopausal defined as
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
no spontaneous menses for a total of 2 years
Description

Absence Menses Spontaneous Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0025344
UMLS CUI [1,3]
C0205359
UMLS CUI [1,4]
C0449238
amenorrheic for at least 12 months with serum oestrogen level <30 pg/ml, and both luteinising hormone (lh)/follicle stimulating hormone (fsh) >20 iu/l, chemotherapy-induced amenorrhoea for at least 12 months
Description

Amenorrhea Duration | Total serum estrogen measurement | Luteinizing hormone measurement | Follicle stimulating hormone measurement | Amenorrhea Chemotherapy Induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C2041290
UMLS CUI [3]
C0202123
UMLS CUI [4]
C0202022
UMLS CUI [5,1]
C0002453
UMLS CUI [5,2]
C3665472
UMLS CUI [5,3]
C0205263
bilateral oophorectomy, or radiation castration and amenorrhoeic for at least 3 months.
Description

Bilateral oophorectomy | Radiation castration | Amenorrhea Duration

Data type

boolean

Alias
UMLS CUI [1]
C0278321
UMLS CUI [2]
C0877129
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
eastern cooperative oncology group (ecog) performance status ≤2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has locally advanced breast cancer that is considered non-operable without neoadjuvant therapy.
Description

Locally advanced breast cancer Inoperable | Neoadjuvant Therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0205187
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0332197
has evidence of metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
as a diagnosis of inflammatory breast cancer
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
has ductal carcinoma in situ
Description

DCIS

Data type

boolean

Alias
UMLS CUI [1]
C0007124
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Similar models

Eligibility Breast Cancer NCT01230970

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Intraductal breast neoplasm Invasive | Invasive Lobular Breast Carcinoma
Item
female subjects 55 to 80 years with histologically or cytologically documented primary intraductal or lobular invasive breast cancer that meets the following criteria:
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0948967 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0279565 (UMLS CUI [4])
TNM Breast tumor staging
Item
t2, n0 or n1, m0.
boolean
C0474926 (UMLS CUI [1])
Tumor size, largest dimension
Item
primary tumour clinically determined to be 2 to 5 cm in the greatest dimension.
boolean
C1272779 (UMLS CUI [1])
Neoplastic Cells Percentage Estrogen receptor positive
Item
laboratory documentation of positive oestrogen receptor (er+) status in at least 10% of the tumour cells.
boolean
C0597032 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0279754 (UMLS CUI [1,3])
HER2 Negative
Item
laboratory documentation of her-2 negative status.
boolean
C2348908 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal defined as
boolean
C0232970 (UMLS CUI [1])
Absence Menses Spontaneous Duration
Item
no spontaneous menses for a total of 2 years
boolean
C0332197 (UMLS CUI [1,1])
C0025344 (UMLS CUI [1,2])
C0205359 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Amenorrhea Duration | Total serum estrogen measurement | Luteinizing hormone measurement | Follicle stimulating hormone measurement | Amenorrhea Chemotherapy Induced
Item
amenorrheic for at least 12 months with serum oestrogen level <30 pg/ml, and both luteinising hormone (lh)/follicle stimulating hormone (fsh) >20 iu/l, chemotherapy-induced amenorrhoea for at least 12 months
boolean
C0002453 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2041290 (UMLS CUI [2])
C0202123 (UMLS CUI [3])
C0202022 (UMLS CUI [4])
C0002453 (UMLS CUI [5,1])
C3665472 (UMLS CUI [5,2])
C0205263 (UMLS CUI [5,3])
Bilateral oophorectomy | Radiation castration | Amenorrhea Duration
Item
bilateral oophorectomy, or radiation castration and amenorrhoeic for at least 3 months.
boolean
C0278321 (UMLS CUI [1])
C0877129 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Locally advanced breast cancer Inoperable | Neoadjuvant Therapy Absent
Item
has locally advanced breast cancer that is considered non-operable without neoadjuvant therapy.
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Neoplasm Metastasis
Item
has evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
as a diagnosis of inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
DCIS
Item
has ductal carcinoma in situ
boolean
C0007124 (UMLS CUI [1])
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